Lyndon L. E. Salins

About Lyndon L. E. Salins

PROFESSIONAL SUMMARYMulti-disciplinary expert who has for 20 years implemented technologically advanced analytical tools to meet customer needs in life science research. 10 years of comprehensive expertise in advancing programs through both early and late-stage development with commercialization of antibody-drug conjugate (ADC) targeted therapeutics.Program manager responsible for late-phase drug development, regulatory support (IND and BLA filings), and client relations. 5 years of experience working in a regulatory environment - extensive knowledge of planning, designing, and implementing new analytical cGMP/GLP processes and procedures. Experienced manager with a passion for quality and customer service and the ability to work in a diverse, highly matrixed, and fast-paced environment. Knowledgeable in R&D, contract manufacturing operations, project management, technical services, product management, and procurement.SKILL HIGHLIGHTSLeadership Supervised teams of up to ten analysts; provided technical training and mentoring to direct reports; deliberative and structured approach to ensure department-wide efficiencies; efficient communicator and outstanding motivator. Organizational and Laboratory Management Superior technical writing skills; authored high quality instructions for user manuals and operating procedures; ability to flawlessly handle multiple projects; proficient in the oversight of work output and safety of employees; capable of working independently or in a team setting composed of diverse groups and situations.Process Improvement Plan Do Study Act (PDSA), 5S, value stream mapping, gemba, root cause analysis, and design of experiment (DOE) initiatives spanning multiple departments both in a leadership role and as a team participant.Bioanalytical Chemistry Method development, qualification, and validation of characterization and chromatography assays for the support of all phases of ADC product development.

Experience

1. Application Manager, Liquid Dose and Biomolecule Formulation

   MilliporeSigma

   Mar 2021 — Present · Fairfield, VA, US

Education

• Berea College

  B.A., Chemistry

  1989 — 1993

• University of Kentucky

  Ph.D., Bioanalytical Chemistry

  1993 — 2000